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Clinical trials for accelerating pandemic vaccines
[‘A Systematic Review of Human Challenge Trials, Designs, and Safety’]

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  • Witold Więcek

Abstract

We provide a short overview of clinical trials of vaccines, with particular focus on (i) adaptive and platform trials, (ii) human challenge trials, and (iii) vaccine use optimization, especially fractional dosing. We describe their relationship with regulatory approval and review main developments during Covid-19. We review the literature on risk–benefit analyses of alternative testing approaches but find few results, suggesting need for further quantitative research. We conclude by discussing some lessons for the next pandemic, such as the need for pre-pandemic R&D and clear guidelines; improving capability to use new trial approaches; arguments for diversifying research methods; research incentives and disincentives; and the need to use risk–benefit in approving new vaccines and targeting.

Suggested Citation

  • Witold Więcek, 2022. "Clinical trials for accelerating pandemic vaccines [‘A Systematic Review of Human Challenge Trials, Designs, and Safety’]," Oxford Review of Economic Policy, Oxford University Press and Oxford Review of Economic Policy Limited, vol. 38(4), pages 797-817.
    • Handle: RePEc:oup:oxford:v:38:y:2022:i:4:p:797-817.
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    File URL: http://hdl.handle.net/10.1093/oxrep/grac029
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    References listed on IDEAS

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    1. Elie Dolgin, 2021. "The tangled history of mRNA vaccines," Nature, Nature, vol. 597(7876), pages 318-324, September.
    2. Markus B Bjoerkheim & Alex Tabarrok, 2022. "Covid in the nursing homes: the US experience [‘The US Bought Rapid Covid-19 Tests to Help Control the Virus. Now Many Are Unused’]," Oxford Review of Economic Policy, Oxford University Press and Oxford Review of Economic Policy Limited, vol. 38(4), pages 887-911.
    3. Witold Więcek & Amrita Ahuja & Michael Kremer & Alexandre Simoes Gomes & Christopher Snyder & Alex Tabarrok & Brandon Joel Tan, 2021. "Could Vaccine Dose Stretching Reduce COVID-19 Deaths?," NBER Working Papers 29018, National Bureau of Economic Research, Inc.
    4. Susan Athey & Juan Camilo Castillo & Esha Chaudhuri & Michael Kremer & Alexandre Simoes Gomes & Christopher M Snyder, 2022. "Expanding capacity for vaccines against Covid-19 and future pandemics: a review of economic issues [‘Seven Finance & Trade Lessons from COVID-19 for Future Pandemics’]," Oxford Review of Economic Policy, Oxford University Press and Oxford Review of Economic Policy Limited, vol. 38(4), pages 742-770.
    5. Donald A. Berry & Scott Berry & Peter Hale & Leah Isakov & Andrew W. Lo & Kien Wei Siah & Chi Heem Wong, 2020. "A Cost/Benefit Analysis of Clinical Trial Designs for COVID-19 Vaccine Candidates," NBER Working Papers 27882, National Bureau of Economic Research, Inc.
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